BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 18631901 · Received February 2, 2024

    Report

    Report Number
    3008514395-2024-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    October 1, 2023
    Report Date
    February 20, 2024
    Manufacturer
    TELCARE LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TELCARE LLC WAS NOT MADE AWARE OF THE EVENT UNTIL (B)(6) 2024 WHEN A HEALTH COACH REACHED OUT TO THE PATIENT TO ENSURE THEY WERE TESTING THEIR BLOOD GLUCOSE REGULARLY. THE PATIENT STATED THAT THE DEVICE WAS THROWN AWAY AND WILL NOT BE RETURNED FOR EVALUATION. WHEN THE PATIENT WAS CONTACTED FOR FOLLOW-UP QUESTIONS, THEY STATED THAT THE DEVICE WAS POWERED ON AND CONNECTED TO A CHARGER WHEN THE EVENT OCCURRED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A COMPLIANCE CALL WAS MADE TO CHECK IN ON THE PATIENT BECAUSE NO NEW BLOOD GLUCOSE READINGS WERE BEING TRANSMITTED FROM THEIR DEVICE. WHEN THE PATIENT ANSWERED, THEY STATED THAT THEY HADN'T BEEN USING THEIR BLOOD GLUCOSE METER BECAUSE IN OCTOBER THE BATTERY IN THE DEVICE EXPLODED AND TORE THE DEVICE APART TO THE POINT IT WAS NOT USABLE. THE PATIENT WAS NOT ABLE TO PROVIDE THE SPECIFIC DATE OF THE EVENT. THE PATIENT INDICATED THAT THEY HAD DISPOSED OF THEIR DEVICE AFTER THE EVENT. NO INJURY WAS REPORTED AND NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278079 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown